No Real-World Advantage for Carotid Stenting Over Surgery

Less-invasive approach not safer in Medicare-linked registry data

Action Points

The effectiveness of cardotid artery stenting (CAS) and carotid endarterectomy (CEA) among Medicare patients was similar for all outcomes (death, stroke, periprocedural myocardial infarction) after adjusting for patient- and provider-level factors.

Note that these data, derived from two large registries, are consistent with the conclusion drawn from the CREST trial, that carotid artery stenting and carotid endarterectomy have similar outcome risks for symptomatic and asymptomatic patients.

Outcomes were similar for Medicare patients with carotid stenosis whether they received stenting or endarterectomy for it, a registry study confirmed.

After adjustment for provider factors -- such as procedural volume, teaching affiliation, and hospital size -- and patient differences, adverse outcome risks were similar for stenting and surgery in terms of:

Thus, "outcomes after carotid artery stenting and carotid endarterectomy among Medicare beneficiaries were comparable after adjusting for both patient and provider-level factors," the group concluded.

"Our results are consistent with the conclusion drawn from CREST that carotid artery stenting and carotid endarterectomy have similar outcome risks for symptomatic and asymptomatic patients," they wrote.

"Although the interaction with symptomatic status in the CREST trial and in our study was not statistically significant, the possibility that carotid endarterectomy may be more beneficial among symptomatic patients cannot be ruled out," the investigators added.

However, "that endarterectomy and stenting are similar in perioperative risks does not mean that patients with asymptomatic stenosis should have these interventions," J. David Spence, MD, of the University of Western Ontario in London, Ontario, told MedPage Today. "The risks are lower with intensive medical therapy for 90% of patients, and the few who could benefit from intervention can be identified by transcranial Doppler embolus detection."

Mark Alberts, MD, of the University of Texas Southwestern Medical Center in Dallas, agreed: "If the patient is asymptomatic, is an intervention even warranted?"

Both stenting and endarterectomy will become more common and important as the population ages, Alberts told MedPage Today in an interview. But he said he will look to the larger CREST 2 trial for answers to whether either intervention can actually outperform optimal medical therapy in this population.

In any case, "carotid artery stenting has been largely developed and promoted as a safer, non-invasive alternative to endarterectomy. Based on these data it certainly does not appear to be safer. It may be as safe -- but its theoretical attractiveness has been that it's safer," Alberts said.

Setoguchi's study included Medicare data from 2000 to 2009 linked to two registries, the Society for Vascular Surgery's Vascular Registry and the National Cardiovascular Data Registry's Carotid Artery Revascularization and Endarterectomy Registry. In total, the study comprised 4,823 stenting and 4,486 endarterectomy patients in a propensity score-matched analysis.

The majority of the patients in both groups were asymptomatic (53% for stenting and 63% for surgery).

Unadjusted outcomes were worse for the stenting patients (HR 1.24, 95% CI 1.06-1.46), who were sicker at baseline and generally at higher surgical risk.

Alberts pointed to the registry study design as a limitation that could make it susceptible to selection bias. Additionally, the study lacked power and "ability to stratify estimates across all subgroups of interest," admitted Setoguchi's group.

She and her colleagues also could not integrate stroke data into their analysis. Finally, they acknowledged that they did not compare either carotid revascularization strategy with medical management.

"Carotid artery stenting seems to be as effective as carotid endarterectomy for the treatment of carotid artery stenosis among Medicare beneficiaries under the National Coverage Decision, especially when performed by qualified providers, but further research is needed to confirm whether older and symptomatic patients may derive greater benefit from carotid endarterectomy than carotid artery stenting," the authors concluded.

Setoguchi reported receiving research support from Johnson & Johnson and consulting for Sanofi-Aventis.

Spence disclosed relationships with the Canadian Institutes for Health Research, the Heart & Stroke Foundation of Canada, the NIH/NINDS, the American Heart Association, the Canadian Journal of Cardiology, the European Stroke Organization, Vanderbilt University Press, McGraw-Hill Medical Publishers, Bayer, Bristol-Myers Squibb, Vascularis, Pfizer, Acasti Pharma, POM Wonderful, CVRx, AGA Medical, and Gore.

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